Department of Neurology, Institute for Research and Medical Care IRCCS San Raffaele Pisana, Rome, Italy.
San Raffaele University, Rome, Italy.
Eur J Neurol. 2021 Jan;28(1):349-354. doi: 10.1111/ene.14552. Epub 2020 Oct 27.
When switching between monoamine oxidase type B (MAO-B) inhibitors, a 15-day suspension period is a precautionary measure to avoid a serotonin syndrome and hypertensive crisis. However, this indication results in a major inconvenience for parkinsonian patients because of the worsening of their clinical condition. In routine clinical practice, neurologists often perform a substitution of these two drugs without solution of continuity (i.e. overnight), to avoid worsening of fluctuations and prolonged OFF periods. Therefore, a safety open label study was performed to investigate the possible risks of switching overnight from rasagiline to safinamide.
The study population included 20 advanced patients with Parkinson's disease on stable treatment with rasagiline and levodopa (alone or in combination with other anti-parkinsonian medication). The possible occurrence of serotonin syndrome and hypertension was monitored through a strict clinical observation and a 24-h Holter recording (ABPM) performed twice, whilst subjects were on rasagiline and immediately after switching to safinamide.
No cases of serotonin syndrome or hypertensive crisis occurred during the study. Changes that were not significant occurred in the primary end-point: 24-h mean blood pressure (BP) had a mild +4.4% increase in the ABPM2 versus ABPM1 (P = 0.17), 24-h systolic and diastolic BP values were slightly higher at ABPM2 compared to ABPM1 (respectively +3.3%, P = 0.13; and 5.4%, P = 0.08) and 24-h systolic BP variability was unchanged between the two ABPM evaluations (from 8.6 ± 2.9 to 8.9 ± 1.8; P = 0.27).
The results of the present study confirm that the overnight switch from rasagiline to safinamide is safe and well tolerated by patients.
当转换单胺氧化酶 B 型（MAO-B）抑制剂时，15 天的停药期是避免血清素综合征和高血压危机的预防措施。然而，由于患者临床状况恶化，这一指示给帕金森病患者带来了很大的不便。在常规临床实践中，神经科医生经常在没有连续性解决方案的情况下（即一夜之间）更换这两种药物，以避免波动加剧和延长关闭期。因此，进行了一项安全性开放标签研究，以调查夜间从雷沙吉兰转换为沙芬酰胺可能存在的风险。
研究人群包括 20 名正在接受雷沙吉兰和左旋多巴（单独或与其他抗帕金森病药物联合使用）稳定治疗的晚期帕金森病患者。通过严格的临床观察和两次 24 小时动态血压监测（ABPM）监测可能出现的血清素综合征和高血压风险，患者在接受雷沙吉兰治疗时和转换为沙芬酰胺后立即进行监测。
研究期间未发生血清素综合征或高血压危机病例。主要终点的变化不显著：ABPM2 与 ABPM1 相比，24 小时平均血压（BP）升高了 4.4%（P=0.17），ABPM2 时 24 小时收缩压和舒张压值略高于 ABPM1（分别为 3.3%，P=0.13；和 5.4%，P=0.08），两次 ABPM 评估之间 24 小时收缩压变异性无变化（从 8.6±2.9 到 8.9±1.8；P=0.27）。
本研究结果证实，雷沙吉兰夜间转换为沙芬酰胺是安全且患者耐受良好的。
